16 days old

Quality Analyst II

Baxalta U.S., Inc.
Thousand Oaks, CA 91362
  • Job Code
    R0037212

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Job Description

Are you looking for a patient-focused, innovation-driven company that will inspire you and empower you to shine? Join us as a Quality Analyst II in our Thousand Oaks, CA office.

At Takeda, we are transforming the pharmaceutical industry through our R&D-driven market leadership and being a values-led company. To do this, we empower our people to realize their potential through life-changing work. Certified as a Global Top Employer, we offer stimulating careers, encourage innovation, and strive for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our global teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world.

Here, you will be a vital contributor to our inspiring, bold mission.

Takeda is a patient-focused, values-based, R&D-driven global biopharmaceutical company committed to bringing Better Health and a Brighter Future to people worldwide. Our passion and pursuit of potentially life-changing treatments for patients are deeply rooted in over 230 years of distinguished history in Japan.

Every vial has a name is a core value at our Thousand Oaks CA campus, a multiproduct facility with over 20 years of operational expertise. We have an excellent opportunity for a high performing Quality Analyst II.

The Quality Analyst II will be responsible for performing the day-to-day quality operations for QA Release Department within the Quality organization. They must identify and assess quality risks in activities and processes according to regulatory agency rules and guidelines and Takeda quality practices. The candidate must have a good understanding of Current Good Manufacturing Practices (CGMP) as well as Good Documentation Practices (GDP).

Essential Duties and Responsibilities

  • Responsible for reviewing pertinent documents, against Standard Operating Procedures (SOPs) for accuracy and compliance to procedures based on regulatory requirements and internal guidelines, etc. which comprises the majority of the work performed.
  • Identify areas of nonconformance and inform management via the drafting of Deviations as needed to be disposed (unilaterally accepted or rejected) by others.
  • Conduct, perform, and/or review investigations for non-conformances within respective area. Investigational activities include description of event, root cause analysis, product impact, corrections, corrective action and/or preventive action. Able to apply problem solving tools and methods to coordinate and/or lead investigation teams. Assist in identifying corrective actions in order to prevent recurring non-conformances.
  • Revise or review standard procedures. Revise SOPs in support of Division Procedure Compliance or continuous improvement efforts as needed.
  • Administer and maintain relevant databases, preparing and issuing reports as defined by the area as well as developing custom reports as needed.
  • Good with Microsoft Excel, Word and PowerPoint
  • Assist in external and internal audits/inspections by maintaining audit records, extracting data from databases and creating reports, collecting relevant data, etc. Support process with timely closure of observations/audit items.
  • Serve as a team member and/or assist in CAPA Investigations for significant issues within respective area.
  • Maintain and update departmental business indicators. Prepare metrics for the Management Review of Quality Systems.
  • Assist in the development and revision of standard operating procedures and in training of employees.
  • Audit/review documents as needed for completeness, cGMPs, company procedures and verification of data. Correct any deficiencies found.
  • Assist and/or prepare Annual Product Review (APR) for products as directed.
  • May perform other duties as assigned.
  • Write Technical reports (e.g. PQR and YBPR)
  • Employee may be required to manage hazardous wastes in compliance with company procedures & State/Federal/Local hazardous waste regulations. Duties may include: identifying, handling, generating, accumulating, storing, labeling, and on-site transporting of hazardous wastes.

Qualifications

  • Strong interpersonal skills and great attention to detail are necessary. Must be a strong team player with good problem solving, and good verbal and written communication skills. Must be able to handle multiple projects concurrently, have computer experience and have knowledge of FDA Regulations, Application of Good Laboratory Practices, and Application of Good Manufacturing Practices.
  • Living our leadership behaviors is a basic expectation for all Takedaemployees.Takeda expects all employees to embody the following:
  • Leadership Behaviors
    • Be Positive
    • Be Accountable
    • Be Results Driven
    • Be an Excellent Manager of Self and Others

Education and/or experience

  • Bachelors degree in a scientific discipline and three - five years of relevant experience or an equivalent combination of education and experience. Masters degree in a scientific discipline and zero one year of relevant experience.

Physical Demand

  • The overall physical exertion of this position is sedentary.
  • The duty of performing tagging or transfer of frozen BDS may require lifting and carrying of up to 10 lbs., occasionally standing or walking and overhead reaching into freezer compartments.
  • Batch record Review on the Floor (BRR) may require being on your feet for long periods of time.

Working Environment

  • Normal office environment.
  • This position requires shift, weekend, and holiday work.
  • May be required to travel for business reasons, e.g. training and meetings.
  • Must be able to work in controlled or clean room environments requiring special gowning. Will be required to follow gowning requirements and wear protective clothing over the head, face, hands, feet and body. No make-up, jewelry, contact lenses, nail polish or artificial fingernails may be worn in these work environments.
  • The incumbent must work in a clean room environment wearing special garments. Additionally, personal protective equipment must be worn due to safety requirements.
  • May work in a cold, wet environment.
  • May be exposed to sunlight and heat.
  • May be exposed to dust, gases, and fumes.
  • Possible exposure to cool/hot storage conditions.
  • May be around moving equipment and machinery.
  • May climb up and into large processing tanks for cleaning or inspection.
  • May be working in a loud area that requires hearing protection and other protective equipment to be worn.
  • May work around chemicals such as alcohol, acids, buffers and celite that may require respiratory protection.
  • May be required to work in a confined area as defined by the Environmental, Health, & Safety office.
  • Inside working conditions.
  • May require immunization before performing work within the manufacturing area.
  • May be required to work or be assigned to a different shift as needed.
  • Must be able to work more than 8 hours a day or 40 hours a workweek as required.
  • Overtime may be required at times.
  • Will have interaction with various departments/personnel.
  • Pace may be fast and job completion demands may be high.

WHAT TAKEDA CAN OFFER YOU:

  • 401(k) with company match and Annual Retirement Contribution Plan
  • Tuition reimbursement Company match of charitable contributions
  • Health & Wellness programs including onsite flu shots and health screenings
  • Generous time off for vacation and the option to purchase additional vacation days
  • Community Outreach Programs

Empowering Our People to Shine

Discover more at takedajobs.com

No Phone Calls or Recruiters Please.

This job posting excludes CO applicants.

Locations

USA - CA - Thousand Oaks - Rancho Conejo

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time





Posted: 2021-06-07 Expires: 2021-07-06
Sponsored by:
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Quality Analyst II

Baxalta U.S., Inc.
Thousand Oaks, CA 91362

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